Braced brachytherapy needle

ABSTRACT

Braces to reduce bending of a brachytherapy needle during insertion into a patient, as well as methods of using the needle braces and kits useful therefor.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation of U.S. Non-Provisional patentapplication Ser. No. 13/515,375 titled Braced Brachytherapy Needle,filed on Jun. 12, 2012, which claims the benefit of International PatentApplication PCT/US10/61764 filed on Dec. 22, 2010, which claims priorityto U.S. Provisional Application 61/289,492, filed Dec. 23, 2009, all ofwhich are hereby incorporated by reference in their entirety.

FIELD OF THE INVENTION

The present invention is directed to the field of brachytherapyequipment. More specifically, the present invention relates to abrachytherapy needle and a brace to help minimize bending of the needleduring needle insertion into a patient.

BACKGROUND OF THE INVENTION

Implanting brachytherapy seeds into a patient typically involves loadinga number of such seeds, possibly including spacers between successiveand either loosely or within a carrier strand, into a brachytherapyimplantation needle. The needles are typically formed from amedically-compliant metal, such as stainless steel. The loaded needletypically includes the seeds at one end within the needle and a styletextending from the seeds out the opposite end of the needle. A grid, ortemplate, providing guide-holes is sometimes positioned against thepatient so that the physician may accurately guide the seeds to theirproper location in or about the target tissue by inserting the needlethrough the proper hole in the grid. The grid body, being about one-inchthick, receives and provides some support to the sharpened end of theneedle. The physician typically drives the needle into the patient bygrasping the needle by its hub at the free end. It is preferable to holdthe needle by the hub so as to reduce the exposure of the hands to theradioactivity of the seeds at the far end. However, as the grid bodyholds the sharp end of the needle and the physician holds the needle bythe hub at the opposite end, dermal resistance to being punctured canlead to buckling stresses on the needle, causing the needle to deflector bow quite noticeably. Once the needle begins to penetrate the throughthe dermis into the perineum, the buckling problem dissipates as theinner tissue provides much less resistance than the dermis.

The buckling problem has been more pronounced as the delivery needlesget smaller in size. For example, the brachytherapy seeds sold asTHINSEED™ (marketed by the General Electric Company through its GEHealthcare business) may be implanted using a 20 gage needle. Thebuckling problem has been observed in some early procedures usingTHINSEED. As the needle passageway is typically filled throughout itslength by seeds and/or spacers and the stylet, permanent deformation ofthe needle due to the penetration compression forces applied to it isless likely. Nevertheless, physicians report that the bowing of theneedle can be a distraction in performing the operation. Physicians willtypically hold the needle body with one hand as the other pushes on theneedle hub to drive the needle into the patient. Such a manual techniqueincreases physician exposure to the activity of the loaded needles.While thicker needles could be employed, thinner needles are desirablefor the lower insult caused to the patient by the smaller tissuedisplacement as the needle passes and the thinner seeds remainimplanted.

There is therefore a need for a device that will limit the deflection ofa brachytherapy needle during penetration. The device should desirablyallow the physician to maintain some stand-off from the seeds within theneedle so as to help minimize extremity exposure to the activity of thebrachytherapy seeds.

SUMMARY OF THE INVENTION

In view of the needs of the prior art, the present invention provides abrachytherapy needle with a brace which reduces bending of the needle asthe needle is inserted into a patient.

The present invention also provides a kit for brachytherapy deviceincluding at least one brachytherapy needle and a brace for minimizingthe bending of the needle as it is inserted into a patient during abrachytherapy implantation procedure.

The present invention also reduces extremity exposure while providinglong axis rigidity to the needle to reduce bowing.

In addition to reducing bowing, the needle assist can be used as a guidefor steering the needle during the penetration process for correct threedimensional placement of the seeds being implanted. This is commonlydone by twisting the luer fitting of the needle and repetitivelyinserting and withdrawing the needle until the desired location isreached. This is also done by guiding the needle by hand, again addingto extremity exposure for the physician.

In addition to eliminating bowing, aiding guidance, and reducingexposure, the needle assist can be used to lock the needle stylet to theluer fitting to ensure the materials within the needle are securedduring insertion to the patient. This is done by creating a removableresistive material between the needle stylet and the needle luerfitting.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 depicts a first brace of the present invention for abrachytherapy needle.

FIG. 2 depicts the brace of FIG. 1 engaging a brachytherapy needleduring an implantation procedure.

FIGS. 3A-G depict alternative shapes for a notch defined by the brace ofFIG. 1.

FIG. 4 depicts an alternative brace of the present invention for abrachytherapy needle.

FIG. 5 depicts the brace of FIG. 4 positioned on a brachtherapy needle.

FIG. 6 depicts the brace of FIG. 4 formed as a bi-component device.

FIG. 7 depicts another brace of the present invention for abrachytherapy device positioned on a brachytherapy needle.

FIG. 8 depicts yet another brace of the present invention positioned ona brachytherapy needle.

FIG. 9 depicts still another brace of the present invention.

FIG. 10 depicts still yet another brace of the present invention.

FIG. 11 depicts even yet another brace of the present invention.

FIG. 12 depicts even still yet another brace of the present invention.

FIG. 13 depicts even still yet another brace of the present invention.

FIG. 14 depicts even still yet another brace of the present invention.

FIG. 15 depicts still yet even another brace of the present invention.

FIGS. 16-18 depicts even still another brace of the present invention.

FIG. 19 depicts yet still another brace of the present invention.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT

The present invention provides braces for brachytherapy needles in orderto reduce bowing (or bending or buckling) of the needle due to thelongitudinal loads during insertion into a patient. The braces offerconvenience to the physicians using the needles by reducing the need tomanually hold the needle at a location near the radioactivebrachytherapy load during needle insertion. Thus, the braces of thepresent invention help reduce extremity exposure to the activity of theneedle loads by either providing the physician some degree of stand-offfrom the needle while manipulating it, and/or through the additionalshielding the brace provides. Certain of the braces are connected to astylet lock at the hub of the needle so as to ensure that the brace doesnot come off of the needle during transportation or handling of theneedle prior to implantation.

The braces may be made of suitable materials which provide thestructural rigidity to minimize bending of the needles during insertioninto a patient. It is further contemplated that the braces may be formedfrom a material, or materials, which provide additional shieldingagainst the activity of the needle loads while also providing asufficient grip on the needle to resist movement due to gravitational orinertial forces. It may be desirable for the braces of the presentinvention to be able to slide along the needle body should the needlepenetrate the patient a distance that is greater than the brace'sclosest distance to either the patient or the needle grid through whichthe needle passes proximate to the patient. Certain braces arecontemplated to be provided with the brace in position on the needlebody, while other braces are to be applied to the needle by thephysician prior to implanting the needle. It is further contemplatedthat any of the braces of the present invention could be provided with abrachytherapy needle in kit form. The needle may be either pre-loadedwith a brachytherapy load. The brachytherapy load being either one ormore brachytherapy seeds and/or spacers, or a stranded brachtherapyproduct where one or more seeds and/or spacers are provided in a carriermaterial or suture as is known in the art.

The operating principle of the present invention is to provide a holdingforce along the needle body so as to reduce the bowing stress, which isa function of body length. Desirably, the brace is applied generallyabout the position of maximum bowing (were it to occur), or at a pointabout mid-way between the needle hub and the placement grid after theneedle has been inserted into the grid but prior to penetration oftissue, although the exact placement may be selected by the physician.Once the needle has penetrated the dermis, the bowing forces aregenerally dissipated as the tissue offers far less resistance to furtherneedle penetration. Thus it is desirable that the brace is able to slidealong the needle body should continued insertion of the needle cause thebrace to run into the grid body.

With reference to FIGS. 1 and 2, the present invention provides a brace10 for a brachytherapy needle. Brace 10 includes an elongate body 12having opposed major surfaces 12 and 14. Body 12 defines a notch 16opening on a perimetrical edge 18 thereof. Notch 16 is defined toinclude a dimension larger than the cross-sectional width (typically,the diameter) of a brachytherapy needle 20.

Needle 20 is a suitable for performing brachytherapy procedures, such as16-gage, 18-gage, or 20-gage needle. Needle 20 has a tubular needle body22 having opposed first and second open ends, 24 and 26 respectively,and an elongate cylindrical body wall 28 extending therebetween. Needlebody 22 defines an elongate passageway 30 extending in fluidcommunication with first and second openings 32 and 34 respectivelydefined by first and second open ends 24 and 26. Needle 20 includes abrachytherapy load positioned within passageway 30 for dispensing outfirst end 24, as is known in the prior art. Needle 20 typically includesa needle hub 36 at second end 26 and an elongate stylet 38 which isextendable through opening 34 and passageway 30 for dispensing thebrachytherapy load.

With particular reference to FIG. 2, needle 20 is typically insertedthrough a grid 40 positioned adjacent to a patient. Grid 40 includes agrid body 42 defining a number of parallel passages 44 therethrough in astandardized 2×2 array used for brachytherapy treatment, or dosing,plans. The physician can push on hub 36 to drive first end 24 of needle20 into the patient towards the target tissue. In order to reduce anybowing, bending, or buckling of needle 20 during needle insertion, thephysician may use their free hand to hold brace 10 so that needle body22 extends generally transversely through notch 16. As the expanse ofnotch 16 is generally slightly larger than the diameter of needle 20,the physician may thus hold brace 10 at an oblique angle a to needlebody 22. Thus, needle body 22 is pinned between opposed notch edges 13and 15 of opposing major surfaces 12 and 14, respectively. It has beendemonstrated that bowing of needle 20 can be reduced or even eliminatedby providing a counter-acting holding force along needle body 22.Desirably, brace 10 is positioned at a location about mid-way betweenhub 36 and grid 40 after needle 20 has been inserted into a passage 44but prior to penetration of tissue.

Referring now to FIGS. 3A-G, the present invention contemplates thatnotch 16 of brace 10 may take different forms and be located atdifferent positions than shown in FIG. 1. In each case, the notch isdefined to include a dimension larger than the cross-sectional width ofsaid needle body so as to receive the needle body therein such that atilting of the brace body with respect to the needle body will providethe desired grip to steady the needle body against bowing. Additionally,for FIGS. 3A-G, like numbering will denote like components.

In FIG. 3A, notch 16 a is defined at a longitudinal end of brace body 10a. Each of the notches which open on a perimetrical edge of the bracebody are contemplated to be located at either a longitudinal end of thebrace body or to open transversely with respect to the brace body. InFIG. 3B, notch 16 b is defined to have a hook-shape. In FIG. 3C, notch16 c is defined to have a first expanse in fluid communication with asecond, larger, expanse. In FIG. 3D, notch 16 d is defined to have theshape of a bayonet-connector, or an L-shape. In FIG. 3E, notch 16 e isdefined by either an arcuate or U-shaped notch edgewall. In FIG. 3F,notch 16F is defined as a bounded arcuate aperture opening on both majorsurfaces of brace body 12 f. In FIG. 3G, notch 16 g is defined asbounded rectilinear aperture opening on both major surfaces of bracebody 12 g.

FIGS. 4-6 depict a brace 110 of the present invention. Brace 110includes an elongate cylindrical brace body, or support body, 112 havingopposed first and second open ends 114 and 116. Brace body 110 includesa needle engagement member 118. Needle engagement member 118 is anelongate cylindrical wall having an inner surface 120 defining anelongate brace passageway 122 extending in fluid communication betweenopen ends 114 and 116. First end 24 of needle 20 is inserted throughbrace passageway 122 so that brace 110 is retained on the outer surface22 a thereof. Brace 110 is desirably sized to slideably engage outersurface 22 a of needle 20, that is, brace 110 is able to hold its placeon needle 20 against gravitational or inertial forces, but is stillrelatively easy to be slid therealong.

Brace 110 may be formed as a unitary structure, as shown in FIG. 4, oras a two-part structure as shown in FIG. 5. In FIG. 5, engagement member118 of brace 110 is provided by an inner cylindrical body 124 extendingwithin support body 112. The present invention contemplates that supportbody 112 is formed from a structurally rigid material to resist thebowing of needle 20 and desirably from a material which attenuatesradioactivity or provides additional shielding to a user or technician.Inner cylindrical body 124 is desirably formed from a softer materialthan support body 112, such as a polymeric material, which can providesome give to needle body on which it is placed.

The longitudinal length of brace 110 may be selected to satisfy thepurpose of the present invention, to reduce the bowing of its respectiveneedle. For example, while brace 110 may be from about 0.25 inches to 1inch in length, the present invention contemplates that the length isonly limited by the length of needle extending between the needle huband the grid body when the needle has reached its maximum insertiondepth. The thickness of brace 10 is selected to be sufficient for theneedle on which it is to be positioned. It is further contemplated thatbrace body 112 forms one or more detents or projections which may bedeflected to engage the needle body onto which it has been positioned.

FIG. 7 depicts brace 210 having a brace body 112 (as described for FIGS.4-6) affixed to a stylet lock 212. Stylet lock 212 includes an annularrim 214 through which stylet 38 extends locking engagement and a spacingarm 216 which holds brace body 112 a fixed distance from hub 36 ofneedle 20. Spacing arm 216 is selected to be a length which still allowsneedle 20 to be inserted to the required dispense depth within thepatient. Stylet lock engages hub 36 and stylet 38 and holds stylet 38 inplace against gravitational and inertial forces but still allows thephysician to advance stylet 38 within the needle passageway to effectdispensing of the brachytherapy load.

FIG. 8 depicts brace 310 having a brace 110 (as described for FIGS. 4-6)affixed to a stylet lock 212 (as described for FIG. 7). Brace 310includes a deflectable spacing arm 316 which limits the maximum spacingof brace body 110 from hub 36 of needle 20, while allowing brace body110 to be urged towards hub 36.

FIG. 9 depicts a brace 410 of the present invention. Brace 410 includesan elongate cylindrical brace body, or support body, 412 having opposedfirst and second open ends 414 and 416. Brace body 412 also defines anelongate transversely-opening channel 415 along the length thereof.Brace body 410 includes a needle engagement member 418. Needleengagement member 418 is an elongate cylindrical wall having an innersurface 420 defining an elongate brace passageway 422 extending in fluidcommunication between open ends 414 and 416. First end 24 of needle 20is inserted through brace passageway 422 so that brace 410 is retainedon the outer surface 22 a thereof. Alternatively, should brace body beformed of a sufficiently flexible material, the present inventioncontemplates that needle 20 may be inserted through channel 415 intopassageway 422. Brace 410 is desirably sized to slideably engage outersurface 22 a of needle 20, that is, brace 410 is able to hold its placeon needle 20 against gravitational or inertial forces, but is stillrelatively easy to be slid therealong. The present inventioncontemplates that brace 410 extends sufficiently about needle 20 toprevent needle 20 from bowing back through channel 415. The presentinvention also contemplates that multiple braces 410 may be applied to asingle needle, in which case it would be desirable to arrange thechannels 415 of each brace to extend in different orientations aboutneedle 20.

FIG. 10 depicts a brace 510 of the present invention. Brace 510 includesa planar body 512 having opposed major faces 514 and 516. Body 512defines a number of passages 518 extending in parallel therethrough,arranged in a 2×2 matrix array corresponding to a brachytherapy doseplan, to open on faces 514 and 516. The present invention contemplatesthat brace 510 may have more than a single needle extendingtherethrough, desirably each needle loaded and positioned in accordancewith the dose plan. As only a single needle will be dispensed at a time,brace 510 may be held by the physician at a location from the dispensingneedle that reduces any bowing of that needle during needle penetrationinto a patient. Brace 510 may be shipped with a carrier kit for a doseplan as is more fully described in copending patent application,attorney docket number PM-0986P, filed on even date herewith, the entirecontents of which are hereby incorporated by reference as if fullydisclosed herein.

FIGS. 11-13 depict various clamp braces of the present invention. Theclamp braces of the present invention provide spring-loaded clamps forholding a portion of a brachytherapy needle at multiple pointstherealong so as to minimize deflection of the needle during insertioninto a patient. The clamps of the present invention are contemplated aseither grasping the surface of the needle at distinct points or along alength of the surface thereof. The clamp braces include opposing firstand second surfaces which are urgeable towards each other by a resilientspring means for engaging the tubular body of said needle. A physicianopens the clamp brace by overcoming the spring means to urge the opposedsurfaces away from each other so that the needle body may be insertedtherebetween. The physician then relaxes the opening force to allow theopposing surfaces to close about the needle body. It is contemplatedthat a single clamp brace may be use for each of the needles providedfor a single dose plan, although each needle may alternatively beprovided with its own clip.

In FIG. 11, clamp brace 610 includes opposing first and second surfaces612 and 614 which are urgeable towards each other by a resilient springmeans 616 for engaging the tubular body of needle 20. Desirably, one orboth of first and second surfaces 612 and 614 defines an elongatearcuate channel 620 and 622 which conform about needle body 22 tothereby provide support fully thereabout. It is contemplated thatarcuate channels 620 and 622 are sized to allow clamp brace 610 to graspand hold onto needle 20 without slippage due to gravitational orinertial forces.

In FIG. 12 clamp brace 710 includes opposing first and second surfaces712 and 714 which are urgeable towards each other by a resilient springmeans 716 for engaging the tubular body of needle 20. Desirably, one orboth of first and second surfaces 712 and 714 defines an elongatearcuate channel 720 and 722. Arcuate channels 720 and 722 thus provide asemi-cylindrical wall which together conform about needle body 22 tothereby provide support thereabout. It is contemplated that arcuatechannels 720 and 722 are sized to allow clamp brace 710 to grasp andhold onto needle 20 without slippage due to gravitational or inertialforces. Clamp brace 710 further includes an elongate first arm 724supporting first surface 712 at one end thereof and an elongate secondarm 726 supporting second surface 714 at one thereof. First and secondarms are pivotally connected so as to allow movement of first surface712 towards and away from second surface 714.

In FIG. 13, clamp brace 810 includes a support member having opposingfirst and second surfaces 812 and 814 which are urgeable towards eachother by a resilient spring means 815 for engaging the tubular body ofneedle 20. First and second surfaces 812 and 814 are provided asopposing surfaces of opposed U-shaped walls 816 and 818. It is furthercontemplated that either U-shaped wall 816 or 818 may be insteadprovided by a pair of transversely-spaced elongate arms 816 a, 816 b or818 a, 818 b, respectively. Clamp brace 810 thus provide two pairs ofspaced hold points for needle 20.

FIG. 14 depicts another brace 910 of the present invention. Brace 910includes a brace body 912 and includes an elongate cylindrical innersurface 914 which defines opposed apertures 916 and 918 and an elongateneedle passage 920 extending in fluid communication therebetween. Bracebody 912 includes an outer surface 922 shaped to ergonomically conformto a user's hand or fingers. The length of body 912 is desirably limitedto allow needle 20 to be inserted to a desired depth within a patient.It is contemplated that brace 910 may be preferably used in procedureswhere a physician desires to grip about needle 20. As such, brace body912 is desirably formed from a radiation-shielding material so as tofurther protect the extremity gripping brace 910.

FIG. 19 depicts another brace 1210 of the present invention. Brace 1210includes an elongate cylindrical brace body 912 having an elongatecylindrical surface 1214 defining opposed apertures 1216 and 1218 and anelongate needle passage 1220 extending in fluid communicationtherebetween. Brace body 1212 includes an elongate cylindrical outersurface 1222. The length of body 1212 is desirably limited to allowneedle 20 to be inserted to a desired depth within the patient. Bracebody further includes a hub-engaging surface 1224 for limiting insertionof needle 20 through passage 1220. Brace body 1212 is desirably formedfrom a radiation-shielding material although may be formed of a suitablemetal or rigid plastic.

FIG. 15 depicts another brace 1010 of the present invention. Brace 1010is similar in concept to braces 210 in that a brace body 110 isconnected to a stylet lock 212 by a two-segment spacing arm 1126.Spacing arm 1026 includes a first segment 1026 a extending from lock 212substantially normal to needle 20 and a second segment 1026 b connectedbetween brace body 112 and first segment 1026 a. Spacing arm 1026 thusprovides a transverse stand-off from the brachytherapy load withinneedle 20 where a physician may hold brace 1010 at a lower risk ofexposure. The present invention further contemplates that the brace 410may be incorporated into this design as well.

FIGS. 16-18 depict brace 1110 of the present invention. Brace 1110 issimilar in concept to brace 310 in that a brace body 1112 is urgeabletowards a stylet lock 1114 located at the needle hub. Brace 1110includes bushing rod 1130 which is receivable within a bushingpassageway 1132 defined by the brace body 1112. The loaded needle isinserted through the aperture in stylet lock 1114 and then throughpassageway 1142 defined through brace body 1112. The needle hub willabuttingly engage stylet lock 1114 as it is too large to pass throughits aperture. The needle hub will travel towards brace body 1112, andthus be inserted into a patient out the opposite end of body 1112, withstylet lock 1114 as bushing rod 1130 extends into bushing passage 1140.The bulk of brace body 1112 will counter the deflection of the needlebody as it is inserted into the patient.

The present invention further provides a kit for a brachytherapyprocedure, the kit includes an elongate needle having a tubular needlebody and a brace of the present invention adapted to engage a portion ofsaid body wall of said needle so as to reduce bending of said needle assaid needle is inserted into a patient. The needle desirably includes atleast one brachytherapy source positioned within said passagewaythereof. The kit desirably also includes an elongate stylet adapted tobe extendable through the needle so as to effect dispensing of thebrachytherapy source. The kit is desirably provided sterilized within asealed container which maintains the sterility of the kit components.

While the particular embodiment of the present invention has been shownand described, it will be obvious to those skilled in the art thatchanges and modifications may be made without departing from theteachings of the invention. The matter set forth in the foregoingdescription and accompanying drawings is offered by way of illustrationonly and not as a limitation. The actual scope of the invention isintended to be defined in the following claims when viewed in theirproper perspective based on the prior art.

What is claimed is:
 1. A brace for a brachytherapy needle comprising: anelongated body; an inner body received within the elongated body anddefining an engagement member configured to slidably receive the needle;and wherein the brace is operative to both reduce bending of the needleduring insertion into a patient and to provide shielding fromradioactivity.
 2. The brace of claim 1, wherein the inner body has asubstantially cylindrical shape.
 3. The brace of claim 1, wherein theelongated body defines an elongated transverse opening.
 4. The brace ofclaim 1, wherein the elongated body and the inner body are formed from afirst material and a second material, respectively, the second materialdifferent than the first material.
 5. The brace of claim 1, wherein theelongated body and the inner body are formed from a first material and asecond material, respectively, the second material softer than the firstmaterial.
 6. The brace of claim 1, wherein the elongated body comprisesat least one projection configured to deflect upon engaging the needle.7. The brace of claim 1 further comprising: a hub-engaging memberconnected to the elongated body and operative to engage a hub of theneedle.
 8. A method of performing brachytherapy on a patient comprising:supporting a needle with a brace so as to reduce bending of the needleduring insertion into a patient; providing shielding from radioactivityvia the brace; and wherein the brace includes an elongated body and aninner body received within the elongated body, the inner body definingan engagement member that slideably receives the needle.
 9. The methodof claim 8 further comprising: implanting a brachytherapy seed into thepatient via the needle.
 10. The method of claim 8, wherein the innerbody has a substantially cylindrical shape.
 11. The method of claim 8,wherein the elongated body defines an elongated transverse opening. 12.The method of claim 8, wherein the elongated body and the inner body areformed from a first material and a second material, respectively, thesecond material different than the first material.
 13. The method ofclaim 8, wherein the elongated body and the inner body are formed from afirst material and a second material, respectively, the second materialsofter than the first material.
 14. The method of claim 8 furthercomprising: engaging the needle with a projection disposed on theelongated body such that the projection deflects.
 15. The method ofclaim 8 further comprising: engaging a hub of the needle with ahub-engaging member connected to the elongated body.
 16. A kit for abrachytherapy procedure comprising: a needle operative to implant a seedinto a patient; a brace for supporting the needle during implantation ofthe seed into the patient; and wherein the brace includes an elongatedbody and an inner body received within the elongated body, the innerbody defining an engagement member operative to slideably receive theneedle.
 17. The kit of claim 16, wherein the inner body has asubstantially cylindrical shape.
 18. The kit of claim 16, wherein theelongated body and the inner body are formed from a first material and asecond material, respectively, the second material different than thefirst material.
 19. The kit of claim 16 further comprising: a styletoperative to be received by the needle.
 20. The kit of claim 19 furthercomprising: a stylet lock operative to hold the stylet in place withrespect to the needle.